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RECRUITING
NCT06598176
NA

Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples

Sponsor: Universiteit Antwerpen

View on ClinicalTrials.gov

Summary

The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.

Official title: Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)

Key Details

Gender

FEMALE

Age Range

25 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-03-28

Completion Date

2037-02-28

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DEVICE

Colli-Pee 20mL device with UCM

Women will collect a first-void urine (the initial part of the urine stream) sample at home the day before a hospital appointment using the 20mL Colli-Pee device prefilled with urine conservation medium (UCM, Novosanis, Belgium).

DEVICE

Evalyn Brush

Women will collect a vaginal self-sample using the Evalyn Brush (Rovers Medical Devices, The Netherlands) at home the day before a hospital appointment.

Locations (1)

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerpen, Belgium